Composition
- Active ingredients
- SOTALOL HYDROCHLORIDE 160MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SOTALOL HYDROCHLORIDE 80MG · TabletNDA019865-001 · Prescription
- SOTALOL HYDROCHLORIDE 320MG · TabletNDA019865-004 · Discontinued
- SOTALOL HYDROCHLORIDE 160MG · TabletThis page
- SOTALOL HYDROCHLORIDE 120MG · TabletNDA019865-005 · Prescription
- SOTALOL HYDROCHLORIDE 240MG · TabletNDA019865-003 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019865.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Betapace
- Active substance
- sotalol hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Legacy Pharma
- Status
- Prescription
- FDA approval
- 30 Oct 1992
- Application
- NDA019865-002